Pharmaceutical Group of the European Union

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Falsified Medicines Directive

PGEU is committed to ensuring that European community pharmacists who are effectively the last line of defence for the patient are at the forefront of the battle against the counterfeiters of medicines.

Falsified medicines pose a major threat to public health and safety. As the counterfeiters become more sophisticated in their methods the risk of falsified medicines entering the supply chain and reaching patients in the EU is increasing every year.

In response to the growing threat of falsified medicines reaching hands of the EU patients, the Falsified Medicines Directive was adopted by the EU in July 2011. It includes a range of measures aimed at preventing falsified medicines entering the supply chain and reaching the hands of patients. The measures include improved inspections, better control of intermediaries, measures to allowing easier identification of legitimate internet sellers, and most importantly for the purposes of this document, the authentication of medicines in the supply chain.

The Delegated Regulation supplementing the Falsified Medicines directive was published on the 9th February 2016. It recognised supply chain partners’ efforts and endorsed the stakeholder model for establishment and management of verification system with a high level of involvement of national competent authorities. According to the Regulation pharmacies are entitled to participate in the legal entity in charge of the verification. It means that by February 2019, supply chain partners in each EU Member State must ensure they have in place end-to-end systems to identify medicines bearing safety features in circulation at the national level under supervision of the national competent authority.

PGEU, along with other medicine supply chain partners, continue to work on implementing the provisions of the Falsified Medicines Directive 2011/62/EU and Delegated Regulation as a member of European Medicines Verification Organisation (EMVO).